Published on February 14, 2020
When Patient Power Co-Founder Andrew Schorr spoke with Dr. Ian Flinn from Tennessee Oncology at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, Dr. Flinn said, “One of the more exciting things that we’re seeing here, at this meeting, is the use of CAR-T cells in the treatment of mantle cell lymphoma.” Just days after that conversation, Gilead announced their application to the FDA for what will be, if approved, the first CAR T-cell therapy for MCL. Exciting indeed!
Excerpt from Gilead Press Release, December 11, 2019:
“Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).”
Gilead’s announcement was a result of a clinical trial called ZUMA-2, led by Dr. Michael Wang from The University of Texas MD Anderson Cancer Center. The results, presented by Dr. Wang at the 2019 ASH Meeting in Orlando, Florida, are most relevant for patients with relapsed MCL—which means the disease has returned—and refractory MCL—which means the disease has stopped responding to treatment.
Excerpt from ASH Clinical News, January 15, 2020:
According to results from the ZUMA-2 trial presented at the 2019 ASH Annual Meeting, 93% of patients with relapsed/refractory mantle cell lymphoma (MCL) responded to treatment with KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. The investigational agent’s safety profile also was consistent with that reported with prior studies of anti-CD19 CAR T-cell therapies.
These promising results from the ZUMA-2 trial provide hope for patients who have previously been treated for MCL. As Dr. Wang explains in a Advances in Treating Mantle Cell Lymphomarecent interview/article_link] with Patient Power’s Esther Schorr, “CAR T-cell therapy is mainly really good for the high-risk patients…they have no other options. They already received chemotherapy, relapsed. They received all the targeted therapy combination, relapsed. There's nothing left. We offer them CAR T-cell therapy…we hope the FDA will approve it very soon, and we absolutely will work to refine it to a better generation.”
KTE-X19 is also currently in Phase I/II trials for the treatment of acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). For emerging news and research updates, subscribe to our Patient Power eNews and follow us on Facebook.
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